Facioscapulohumeral Muscular Dystrophy Market Gearing Up for Outstanding Expansion Across the 7MM During the Forecast Period (2025-2034)
LAS VEGAS, July 17, 2025 /PRNewswire/ — Facioscapulohumeral muscular dystrophy (FSHD) often starts with muscle weakness in the face, shoulders, and upper arms, and gradually progresses to affect the abdominal muscles, legs, and pelvic area as the disease advances. Symptoms commonly emerge during childhood or adolescence, though they can begin at any stage of life, from infancy to old age. There is considerable variation in symptom onset and severity, even among relatives with the condition.
Roughly 80% of individuals carrying the FSHD gene mutation experience symptoms, while the remaining 20% are asymptomatic, either showing no signs or only very mild symptoms that may go unnoticed until later in life. For FSHD1, children of an affected parent have a 50% likelihood of inheriting the disorder. In FSHD2, the inheritance risk depends on the genetic background of both parents, typically ranging from 25% to 50%.
In 2024, the United States represented about 45% of all FSHD cases across the 7MM, with numbers projected to rise by 2034. Most US patients in 2024 scored between 7 and 10 on the RICCI scale, indicating moderate to severe levels of muscle dysfunction.
Download the report to understand which factors are driving FSHD epidemiology trends @ Facioscapulohumeral Muscular Dystrophy Treatment Algorithm
At present, there are no available therapies that can slow, halt, or reverse the progression of muscle weakness in facioscapulohumeral muscular dystrophy. While physical therapy can be beneficial in some cases, it is generally recommended that individuals engage in regular low-resistance and aerobic exercise. Collaborating with a physical therapist is important to create a personalized and safe exercise regimen.
Some patients may benefit from surgical stabilization of the scapula to enhance their ability to raise their arms above shoulder level. Scapular fixation involves anchoring the shoulder blades to the ribs and may be performed on one or both sides. This is a complex procedure that should only be undertaken by skilled surgeons after thorough evaluation and discussion with both the surgeon and the neurologist. Additionally, medications such as NSAIDs, opioids, and antidepressants are commonly prescribed to manage FSHD-related pain.
Current care practices are centered around managing complications and preserving physical function. Rehabilitation consultations are advised for individuals facing mobility or functional issues. However, there remains a significant unmet need for effective and affordable approved therapies, as existing supportive treatments are often costly and limited in efficacy.
Learn more about the FSHD treatment @ New Treatment for Facioscapulohumeral Muscular Dystrophy
There remains a significant unmet need in the treatment of FSHD, as current approaches primarily involve off-label therapies. Management strategies are largely aimed at alleviating symptoms and preserving physical function. Although FSHD is a progressive disorder with potentially serious long-term effects, treatment options are still limited to symptomatic care.
Several investigational therapies are in development, including GYM329/RO7204239/RG6237 by Roche and Chugai Pharmaceutical, Delpacibart braxlosiran (del-brax) by Avidity Biosciences, EPI-321 by Epicrispr Biotechnologies, among others.
Discover which therapies are expected to grab major FSHD market share @ Facioscapulohumeral Muscular Dystrophy Market Report
GYM329 (also known as RO7204239 or RG6237) is an experimental anti-myostatin antibody aimed at enhancing skeletal muscle mass and growth. It has been specifically engineered as a 'recycling' and 'sweeping' antibody, meaning it may clear myostatin from the bloodstream more effectively than traditional antibodies. This targeted approach is expected to help address conditions marked by muscle wasting and reduced muscle strength. In November 2022, Roche began a Phase II clinical trial (NCT05548556) in patients with facioscapulohumeral muscular dystrophy, and according to the company, regulatory filing is anticipated after 2028.
As per Chugai Pharmaceutical's Q1 2025 update, results from the ongoing MANOEUVRE Phase II study for FSHD are expected in 2025. With proof of concept established, Chugai plans to advance to Phase III trials, set to begin in 2026.
Delpacibart braxlosiran (del-brax, formerly AOC 1020) is currently being assessed in the Phase I/II FORTITUDE trial (NCT06547216) in both adult and adolescent participants with FSHD. This study is focused on evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenously administered del-brax.
In June 2025, Avidity Biosciences announced that del-brax may qualify for an accelerated approval pathway in the U.S. for FSHD treatment. The company also launched the global Phase III FORWARD trial to serve as a confirmatory study for full regulatory approval. Additionally, Avidity reported positive topline results from the dose-escalation cohorts of the FORTITUDE trial, which will be shared at the 32nd Annual FSHD Society International Research Congress.
EPI-321 is an investigational, one-time gene-silencing therapy targeting abnormal DUX4 expression. Administered systemically via a validated AAV vector, EPI-321 has shown strong preclinical results, including effective suppression of DUX4 and preservation of muscle tissue. It has received Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the FDA. The company is preparing to launch a global Phase I/II trial in 2025.
Discover more about drugs for FSHD in development @ Facioscapulohumeral Muscular Dystrophy Clinical Trials
The anticipated launch of these emerging therapies for FSHD are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the FSHD market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
DelveInsight estimates that the market size for FSHD is expected to grow at a significant CAGR by 2034. This growth is mainly driven by increased awareness, improved diagnostic techniques, and ongoing research into genetic therapies. Rising investment from pharmaceutical companies and the emergence of targeted therapies are expanding treatment options. Regulatory support for orphan diseases is also accelerating drug development.
DelveInsight's latest published market report, titled as Facioscapulohumeral Muscular Dystrophy Market Insight, Epidemiology, and Market Forecast – 2034, will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the FSHD country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The FSHD market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
Total Prevalent Cases of FSHD
Total Diagnosed Prevalent Cases of FSHD
Type-specific Diagnosed Prevalent Cases of FSHD
Gender-specific Diagnosed Prevalent Cases of FSHD
Age-specific Diagnosed Prevalent Cases of FSHD
Severity-specific Diagnosed Prevalent Cases of FSHD
Total Treated Cases of FSHD
The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM FSHD market. Highlights include:
10-year Forecast
7MM Analysis
Epidemiology-based Market Forecasting
Historical and Forecasted Market Analysis upto 2034
Emerging Drug Market Uptake
Peak Sales Analysis
Key Cross Competition Analysis
Industry Expert's Opinion
Access and Reimbursement
Download this FSHD market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the FSHD market. Also, stay abreast of the mitigating factors to improve your market position in the FSHD therapeutic space.
Related Reports
Facioscapulohumeral Muscular Dystrophy Pipeline
Facioscapulohumeral Muscular Dystrophy Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key FSHD companies, including Fulcrum Therapeutics, Dyne Therapeutics, Hoffmann-La Roche, aTyr Pharma, Inc., Avidity Biosciences, Inc., among others.
Facioscapulohumeral Muscular Dystrophy Epidemiology Forecast
Facioscapulohumeral Muscular Dystrophy Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted FSHD epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
Duchenne Muscular Dystrophy Market
Duchenne Muscular Dystrophy Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key DMD companies, including Sarepta Therapeutics, PTC Therapeutics, Nippon Shinyaku, Santhera Pharmaceuticals, ReveraGen BioPharma, Taiho Pharmaceutical, FibroGen, Capricor, Daiichi Sankyo, Italfarmaco, Antisense Therapeutics, Solid Biosciences, among others.
Spinal Muscular Atrophy Market
Spinal Muscular Atrophy Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SMA companies, including Scholar Rock, Biogen, Astellas Pharma, Alcyone Therapeutics, AndroScience Corporation, Hanugen Therapeutics, Voyager Therapeutics, Hoffmann-La Roche, Catalyst Pharmaceuticals, NMD Pharma, Biohaven Pharmaceuticals, CANbridge Pharmaceuticals Inc., Aurimed Pharma, Exicure, Amylon Therapeutics, Amniotics, among others.
About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.
Contact Us Shruti Thakur info@delveinsight.com +14699457679
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To know more about SERM clinical trials, visit @ SERM Treatment SERM Overview Selective estrogen receptor modulators (SERMs), also referred to as estrogen receptor agonists/antagonists (ERAAs), are a group of compounds that interact with estrogen receptors (ERs). Unlike full agonists or pure antagonists, SERMs exhibit tissue-specific actions, meaning they can either stimulate or block estrogenic effects depending on the target tissue. This selective behavior is due to their ability to bind to the two estrogen receptor subtypes, ERα and ERβ, in ways that influence their activity uniquely across different tissues. The resulting effects are determined by how SERMs modify signaling pathways in a tissue-dependent manner, rather than by directly altering DNA. In the context of bone health, SERMs help regulate bone metabolism by decreasing osteoclast activity via a mechanism involving transforming growth factor-β3, leading to reduced bone resorption and thereby supporting the prevention and treatment of osteoporosis. SERM Epidemiology Segmentation The SERM market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Cases of Selected Indication for SERM Total Eligible Patients of the Selected Indications Total Treated Cases in Selected Indications for SERMs SERM Report Metrics Details Study Period 2020–2034 SERM Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key Indications Covered in the Report Breast cancer, Postmenopausal osteoporosis, Dyspareunia and vaginal dryness, and others Key SERM Companies Atossa Therapeutics, Sermonix Pharmaceuticals, Duchesnay, Pfizer, Eli Lilly, and others Key SERM (Z)-Endoxifen, Lasofoxifene, OSPHENA, DUAVEE, EVISTA (raloxifene hydrochloride), FABLYN, and others Scope of the SERM Market Report SERM Therapeutic Assessment: SERM current marketed and emerging therapies SERM Market Dynamics: Conjoint Analysis of Emerging SERM Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, SERM Market Access and Reimbursement Discover more about SERMs in development @ SERM Clinical Trials Table of Contents 1 Key Insights 2 Report Introduction 3 Executive Summary of SERM 4 Key Events 5 Market Forecast Methodology 6 SERM Market Overview at a Glance in the 7MM 6.1 Market Share (%) Distribution by Indication in 2024 6.2 Market Share (%) Distribution by Indication in 2034 7 SERM: Background and Overview 8 Treatment and Management 9 Target Patient Pool 9.1 Key Findings 9.2 Assumptions and Rationale: 7MM 9.3 Epidemiology Scenario in the 7MM 9.3.1 Total Cases of Selected Indication for SERM in the 7MM 9.3.2 Total Eligible Patient Pool for SERM in Selected Indication in the 7MM 9.3.3 Total Treatable Cases in Selected Indication for SERM in the 7MM 10 Marketed Therapies 10.1 Key Competitors 10.2 OSPHENA (ospemifene): Duchesnay 10.2.1 Product Description 10.2.2 Regulatory milestones 10.2.3 Other developmental activities 10.2.4 Clinical development 10.2.5 Safety and efficacy 10.3 DUAVEE (conjugated estrogens/bazedoxifene): Pfizer 10.3.1 Product Description 10.3.2 Regulatory milestones 10.3.3 Other developmental activities 10.3.4 Clinical development 10.3.5 Safety and efficacy List to be continued in the report… 11 Emerging Therapies 11.1 Key Competitors 11.2 (Z)-Endoxifen: Atossa Therapeutics 11.2.1 Product Description 11.2.2 Other developmental activities 11.2.3 Clinical development 11.2.4 Safety and efficacy 11.3 Lasofoxifene: Sermonix Pharmaceuticals 11.3.1 Product Description 11.3.2 Other developmental activities 11.3.3 Clinical development 11.3.4 Safety and efficacy List to be continued in the report… 12 SERM: Seven Major Market Analysis 12.1 Key Findings 12.2 Market Outlook 12.3 Conjoint Analysis 12.4 Key Market Forecast Assumptions 12.4.1 Cost Assumptions and Rebates 12.4.2 Pricing Trends 12.4.3 Analogue Assessment 12.4.4 Launch Year and Therapy Uptakes 12.5 Total Market Size of SERM in the 7MM 12.6 The United States 12.7 EU4 and the UK 12.8 Japan 13 SWOT Analysis of SERM 14 KOL Views of SERM 15 Unmet Needs of SERM 16 Market Access and Reimbursement 17 Bibliography 18 Report Methodology Related Reports Metastatic HR+/HER2− Breast Cancer Market Metastatic HR+/HER2− Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic HR+/HER2− breast cancer companies, including Merck, Arvinas, Olema Pharmaceuticals, Celcuity, Roche, AstraZeneca, Daiichi Sankyo, Eli Lilly, Sermonix Pharmaceuticals, Genentech, Veru Pharma, DualityBio, BioNtech, Evgen Pharma, Carrick Therapeutics, EQRx, G1 Therapeutics, Immutep, among others. 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